NCT02013921

Brief Summary

Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types. It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice. To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry . Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity. Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive. In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 11, 2019

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

November 25, 2013

Last Update Submit

January 9, 2019

Conditions

Keywords

Physical activityCancer

Outcome Measures

Primary Outcomes (1)

  • Daily physical activity assessment at 3 months

    Physical activity is measured by means of an Actigraph. Patients will measure their daily physical activity , three times during one week espaced by 1 month.

    Month 3

Study Arms (1)

Physical Activity

Patients with a breast cancer and are completing treatment

Other: Physical activity

Interventions

Physical Activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a breast cancer and are completing treatment

You may qualify if:

  • adult (age ≥ 18 years)
  • Having been informed of the study orally and in writing and have not expressed opposition to his participation
  • Performance status \<2
  • Invasive breast adenocarcinoma, histologically documented.
  • Patients with a breast cancer and are completing treatment

You may not qualify if:

  • Patient with metastatic cancer.
  • Patient for which monitoring required by the protocol is impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncologie- CHU Limoges

Limoges, 87000, France

Location

MeSH Terms

Conditions

NeoplasmsFatigueMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 17, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 11, 2019

Record last verified: 2015-04

Locations